Budesonide Nasal
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Uses
Budesonide nasal spray is indicated for the treatment of nasal symptoms of seasonal or perennial allergic rhinitis in adults and children six years of age and older.
History
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Other Information
Budesonide, the active ingredient of Budesonide Nasal Spray, is an anti-inflammatory synthetic corticosteroid.
It is designated chemically as (RS)-11-beta, 16-alpha, 17, 21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16, 17-acetal with butyraldehyde.
Budesonide is provided as the mixture of two epimers (22R and 22S).
The empirical formula of budesonide is C25H34O6 and its molecular weight is 430.5.
Its structural formula is:
Budesonide is a white or almost white, crystalline powder that is practically insoluble in water and in heptane, sparingly soluble in ethanol, and freely soluble in chloroform.
Its partition coefficient between octanol and water at pH 5 is 1.6 x 103.
Budesonide nasal spray is an unscented, metered-dose, manual-pump spray formulation containing a micronized suspension of budesonide in an aqueous medium. Microcrystalline cellulose and carboxymethyl cellulose sodium, dextrose anhydrous, polysorbate 80, disodium edetate, potassium sorbate, and purified water are contained in this medium; hydrochloric acid is added to adjust the pH to a target of 4.0 to 5.0.
Budesonide nasal spray delivers 32 mcg of budesonide per spray.
Each bottle of budesonide nasal spray 32 mcg contains 120 metered sprays after initial priming.
Prior to initial use, the container must be shaken gently and the pump must be primed by actuating eight times. If used daily, the pump does not need to be reprimed. If not used for two consecutive days, reprime with one spray or until a fine spray appears. If not used for more than 14 days, rinse the applicator and reprime with two sprays or until a fine spray appears.
Sources
Budesonide Nasal Manufacturers
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Apotex Corp.
![Budesonide Nasal (Budesonide) Spray, Metered [Apotex Corp.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Budesonide Nasal | Apotex Corp.
The recommended starting dosage for adults and children 6 years of age and older is 64 mcg per day administered as one spray per nostril of budesonide nasal spray 32 mcg once daily. Some patients who do not achieve symptom control at the recommended starting dosage may benefit from an increased dosage. The maximum recommended dosage for adults (12 years of age and older) is 256 mcg per day administered as four sprays per nostril once daily of budesonide nasal spray 32 mcg and the maximum recommended dose for pediatric patients (6 to <12 years of age) is 128 mcg per day administered as two sprays per nostril once daily of budesonide nasal spray 32 mcg.
It is always desirable to titrate an individual patient to the minimum effective dosage to reduce the possibility of side effects. An improvement in nasal symptoms may be noted in patients within 10 hours of first using budesonide nasal spray, however, clinical improvement usually takes 1-2 days with maximum benefit in approximately 2 weeks. When the maximum benefit has been achieved and symptoms have been controlled, reducing the dosage may be effective in maintaining control of the allergic rhinitis symptoms in patients who were initially controlled on higher dosages.
Prior to initial use, the container must be shaken gently and the pump must be primed by actuating eight times. If used daily, the pump does not need to be reprimed. If not used for two consecutive days, reprime with one spray or until a fine spray appears. If not used for more than 14 days, rinse the applicator and reprime with two sprays or until a fine spray appears. Shake the container gently before each use.
Illustrated Patient’s Instructions for Use accompany each package of budesonide nasal spray 32 mcg.
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